Hydraulic systems for delivering prosthetic heart valve devices and associated methods

ABSTRACT

Systems for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, an elongated catheter body, a delivery capsule carried by the elongated catheter body, and two fluid chambers within the delivery capsule. The delivery capsule can be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for at least partially deploying the prosthetic heart valve device. For example, the delivery capsule can be urged towards the deployment configuration when fluid is removed from the first chamber and fluid is delivered into the second chamber, whereas the delivery capsule can be urged towards the containment configuration to resheathe the prosthetic heart valve device when fluid is removed from the second chamber and delivered into the first chamber.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application incorporates the subject matter of (1)International Patent Application No. PCT/US2014/029549, filed Mar. 14,2014, (2) International Patent Application No. PCT/US2012/061219, filedOct. 19, 2012, (3) International Patent Application No.PCT/US2012/061215, filed Oct. 19, 2012, (4) International PatentApplication No. PCT/US2012/043636, filed Jun. 21, 2012. The presentapplication also incorporates the subject matter of U.S. ApplicationSer. No. 15/490,024, filed concurrently herewith.

TECHNICAL FIELD

The present technology relates generally to systems for deliveringprosthetic heart valve devices. In particular, several embodiments ofthe present technology are related to hydraulic systems forpercutaneously delivering prosthetic heart valve devices into mitralvalves and associated methods.

BACKGROUND

Heart valves can be affected by several conditions. For example, mitralvalves can be affected by mitral valve regurgitation, mitral valveprolapse and mitral valve stenosis. Mitral valve regurgitation isabnormal leaking of blood from the left ventricle into the left atriumcaused by a disorder of the heart in which the leaflets of the mitralvalve fail to coapt into apposition at peak contraction pressures. Themitral valve leaflets may not coapt sufficiently because heart diseasesoften cause dilation of the heart muscle, which in turn enlarges thenative mitral valve annulus to the extent that the leaflets do not coaptduring systole. Abnormal backflow can also occur when the papillarymuscles are functionally compromised due to ischemia or otherconditions. More specifically, as the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulgeabnormally up in to the left atrium. This can cause irregular behaviorof the mitral valve and lead to mitral valve regurgitation. The leafletsmay prolapse and fail to coapt because the tendons connecting thepapillary muscles to the inferior side of the mitral valve leaflets(chordae tendineae) may tear or stretch. Mitral valve stenosis is anarrowing of the mitral valve orifice that impedes filling of the leftventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/orvasodilators to reduce the amount of blood flowing back into the leftatrium. Surgical approaches (open and intravascular) for either therepair or replacement of the valve have also been used to treat mitralvalve regurgitation. For example, typical repair techniques involvecinching or resecting portions of the dilated annulus. Cinching, forexample, includes implanting annular or peri-annular rings that aregenerally secured to the annulus or surrounding tissue. Other repairprocedures suture or clip the valve leaflets into partial appositionwith one another.

Alternatively, more invasive procedures replace the entire valve itselfby implanting mechanical valves or biological tissue into the heart inplace of the native mitral valve. These invasive proceduresconventionally require large open thoracotomies and are thus verypainful, have significant morbidity, and require long recovery periods.Moreover, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may cause additional problems for the patient. Repair proceduresalso require a highly skilled cardiac surgeon because poorly orinaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have beenimplemented in recent years. Examples of pre-assembled, percutaneousprosthetic valves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame and a tri-leaflet bioprostheticvalve attached to the expandable frame. The aortic valve issubstantially symmetric, circular, and has a muscular annulus. Theexpandable frames in aortic applications have a symmetric, circularshape at the aortic valve annulus to match the native anatomy, but alsobecause tri-leaflet prosthetic valves require circular symmetry forproper coaptation of the prosthetic leaflets. Thus, aortic valve anatomylends itself to an expandable frame housing a replacement valve sincethe aortic valve anatomy is substantially uniform, symmetric, and fairlymuscular. Other heart valve anatomies, however, are not uniform,symmetric or sufficiently muscular, and thus transvascular aortic valvereplacement devises may not be well suited for other types of heartvalves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. The headings provided herein are forconvenience only.

FIG. 1 is a schematic, cross-sectional illustration of the heart showingan antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 2 is a schematic, cross-sectional illustration of the heart showingaccess through the inter-atrial septum (IAS) maintained by the placementof a guide catheter over a guidewire in accordance with variousembodiments of the present technology.

FIGS. 3 and 4 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 5 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 6 is an isometric view of a system for delivering a prostheticheart valve device configured in accordance with an embodiment of thepresent technology.

FIG. 7A is a partially schematic illustration of a distal portion of thesystem of FIG. 6 positioned in a native mitral valve of a heart using atrans-apical delivery approach in accordance with embodiments of thepresent technology.

FIG. 7B is a partially schematic illustration of the distal portion ofthe system of FIG. 7A in a deployment configuration and a deployedprosthetic heart valve device in accordance with embodiments of thepresent technology.

FIGS. 8A and 8B are partially schematic cross-sectional views of thedelivery system of FIG. 6 in a containment configuration (FIG. 8A) and adeployment configuration (FIG. 8B) in accordance with an embodiment ofthe present technology.

FIGS. 9A and 9B are cross-sectional views of a distal portion of adelivery system for a prosthetic heart valve device in a partiallyretained state (FIG. 9A) and in a fully deployed state (FIG. 9B) inaccordance with another embodiment of the present technology.

FIG. 9C is a top view of an engagement pedestal of the delivery systemof FIGS. 9A and 9B configured in accordance with an embodiment of thepresent technology.

FIGS. 10A-10C are a series of partially schematic illustrations of adistal portion of a delivery system deploying a prosthetic a prostheticheart valve device within a native mitral valve of a heart using atrans-septal approach in accordance with further embodiments of thepresent technology.

FIGS. 11A and 11B are enlarged, partially schematic cross-sectionalviews of a distal portion of a trans-septal delivery system in apartially expanded deployment configuration (FIG. 11A) and a containmentconfiguration (FIG. 11B) in accordance with another embodiment of thepresent technology.

FIG. 12A is a cross-sectional side view and FIG. 12B is a top viewschematically illustrating a prosthetic heart valve device in accordancewith an embodiment of the present technology.

FIGS. 13A and 13B are cross-sectional side views schematicallyillustrating aspects of delivering a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 14 is a top isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 15 is a side view and FIG. 16 is a bottom isometric view of theprosthetic heart valve device of FIG. 14.

FIG. 17 is a side view and FIG. 18 is a bottom isometric view of aprosthetic heart valve device in accordance with an embodiment of thepresent technology.

FIG. 19 is a side view and FIG. 20 is a bottom isometric view of theprosthetic heart valve device of FIGS. 17 and 18 at a partially deployedstate with respect to a delivery device.

FIG. 21 is an isometric view of a valve support for use with prostheticheart valve devices in accordance with the present technology.

FIGS. 22 and 23 are side and bottom isometric views, respectively, of aprosthetic heart valve attached to the valve support of FIG. 21.

FIGS. 24 and 25 are side views schematically showing valve supports inaccordance with additional embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to hydraulic systems fordelivering prosthetic heart valve devices and associated methods.Specific details of several embodiments of the present technology aredescribed herein with reference to FIGS. 1-25. Although many of theembodiments are described with respect to devices, systems, and methodsfor delivering prosthetic heart valve devices to a native mitral valve,other applications and other embodiments in addition to those describedherein are within the scope of the present technology. For example, atleast some embodiments of the present technology may be useful fordelivering prosthetics to other valves, such as the tricuspid valve orthe aortic valve. It should be noted that other embodiments in additionto those disclosed herein are within the scope of the presenttechnology. Further, embodiments of the present technology can havedifferent configurations, components, and/or procedures than those shownor described herein. Moreover, a person of ordinary skill in the artwill understand that embodiments of the present technology can haveconfigurations, components, and/or procedures in addition to those shownor described herein and that these and other embodiments can be withoutseveral of the configurations, components, and/or procedures shown ordescribed herein without deviating from the present technology.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can referencerelative positions of portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a location where blood flows into the device (e.g., inflowregion), and distal can refer to a downstream position or a locationwhere blood flows out of the device (e.g., outflow region).

Overview

Several embodiments of the present technology are directed to deliverysystems and mitral valve replacement devices that address the uniquechallenges of percutaneously replacing native mitral valves and arewell-suited to be recaptured in a percutaneous delivery device afterbeing partially deployed for repositioning or removing the device.Compared to replacing aortic valves, percutaneous mitral valvereplacement faces unique anatomical obstacles that render percutaneousmitral valve replacement significantly more challenging than aorticvalve replacement. First, unlike relatively symmetric and uniform aorticvalves, the mitral valve annulus has a non-circular D-shape orkidney-like shape, with a non-planar, saddle-like geometry often lackingsymmetry. The complex and highly variable anatomy of mitral valves makesit difficult to design a mitral valve prosthesis that conforms well tothe native mitral annulus of specific patients. As a result, theprosthesis may not fit well with the native leaflets and/or annulus,which can leave gaps that allows backflow of blood to occur. Forexample, placement of a cylindrical valve prosthesis in a native mitralvalve may leave gaps in commissural regions of the native valve throughwhich perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for use in mitral valves. First, many ofthese devices require a direct, structural connection between thestent-like structure that contacts the annulus and/or leaflets and theprosthetic valve. In several devices, the stent posts which support theprosthetic valve also contact the annulus or other surrounding tissue.These types of devices directly transfer the forces exerted by thetissue and blood as the heart contracts to the valve support and theprosthetic leaflets, which in turn distorts the valve support from itsdesired cylindrical shape. This is a concern because most cardiacreplacement devices use tri-leaflet valves, which require asubstantially symmetric, cylindrical support around the prosthetic valvefor proper opening and closing of the three leaflets over years of life.As a result, when these devices are subject to movement and forces fromthe annulus and other surrounding tissues, the prostheses may becompressed and/or distorted causing the prosthetic leaflets tomalfunction. Moreover, a diseased mitral annulus is much larger than anyavailable prosthetic aortic valve. As the size of the valve increases,the forces on the valve leaflets increase dramatically, so simplyincreasing the size of an aortic prosthesis to the size of a dilatedmitral valve annulus would require dramatically thicker, tallerleaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over thecourse of each heartbeat, the mitral valve annulus lacks a significantamount of radial support from surrounding tissue. Compared to aorticvalves, which are completely surrounded by fibro-elastic tissue thatprovides sufficient support for anchoring a prosthetic valve, mitralvalves are bound by muscular tissue on the outer wall only. The innerwall of the mitral valve anatomy is bound by a thin vessel wallseparating the mitral valve annulus from the inferior portion of theaortic outflow tract. As a result, significant radial forces on themitral annulus, such as those imparted by an expanding stent prostheses,could lead to collapse of the inferior portion of the aortic tract.Moreover, larger prostheses exert more force and expand to largerdimensions, which exacerbates this problem for mitral valve replacementapplications.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. Unlike aortic valves, mitralvalves have a maze of cordage under the leaflets in the left ventriclethat restrict the movement and position of a deployment catheter and thereplacement device during implantation. As a result, deploying,positioning and anchoring a valve replacement device on the ventricularside of the native mitral valve annulus is complicated.

Embodiments of the present technology provide systems, methods andapparatus to treat heart valves of the body, such as the mitral valve,that address the challenges associated with the anatomy of the mitralvalve and provide for repositioning and removal of a partially deployeddevice. The apparatus and methods enable a percutaneous approach using acatheter delivered intravascularly through a vein or artery into theheart, or through a cannula inserted through the heart wall. Forexample, the apparatus and methods are particularly well-suited fortrans-septal and trans-apical approaches, but can also be trans-atrialand direct aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. Additionally, the embodiments of the devices andmethods as described herein can be combined with many known surgeriesand procedures, such as known methods of accessing the valves of theheart (e.g., the mitral valve or triscuspid valve) with antegrade orretrograde approaches, and combinations thereof.

The systems and methods described herein facilitate controlled deliveryof a prosthetic heart valve device using trans-apical or trans-septaldelivery approaches and allow resheathing of the prosthetic heart valvedevice after partial deployment of the device to reposition and/orremove the device. The delivery systems can include two independentfluid chambers that are interchangeably filled with fluid and drained offluid to initiate deployment and resheathing of the prosthetic device.This facilitates hydraulic control and power for both proximal anddistal movement of a capsule housing that provides for controlleddelivery of the prosthetic heart valve device and inhibits uncontrolledmovement of the delivery system resulting from forces associated withexpansion of the prosthetic heart valve device (e.g., axial jumping,self-ejection, etc.). In addition, the hydraulic delivery systemsdisclosed herein can inhibit longitudinal translation of the prostheticheart valve device relative to the treatment site while the prostheticheart valve device moves between the containment configuration and thedeployment configuration. This allows the clinician to position thesheathed prosthetic heart valve device at the desired target site fordeployment, and then deploy the device at that target site withoutneeding to compensate for any axial movement caused by deployment.

Access to the Mitral Valve

To better understand the structure and operation of valve replacementdevices in accordance with the present technology, it is helpful tofirst understand approaches for implanting the devices. The mitral valveor other type of atrioventricular valve can be accessed through thepatient's vasculature in a percutaneous manner. By percutaneous it ismeant that a location of the vasculature remote from the heart isaccessed through the skin, typically using a surgical cut down procedureor a minimally invasive procedure, such as using needle access through,for example, the Seldinger technique. The ability to percutaneouslyaccess the remote vasculature is well known and described in the patentand medical literature. Depending on the point of vascular access,access to the mitral valve may be antegrade and may rely on entry intothe left atrium by crossing the inter-atrial septum (e.g., atrans-septal approach). Alternatively, access to the mitral valve can beretrograde where the left ventricle is entered through the aortic valve.Access to the mitral valve may also be achieved using a cannula via atrans-apical approach. Depending on the approach, the interventionaltools and supporting catheter(s) may be advanced to the heartintravascularly and positioned adjacent the target cardiac valve in avariety of manners, as described herein.

FIG. 1 illustrates a stage of a trans-septal approach for implanting avalve replacement device. In a trans-septal approach, access is via theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the inter-atrial septum IAS, and into the left atriumLA above the mitral valve MV. As shown in FIG. 1, a catheter 1 having aneedle 2 moves from the inferior vena cava IVC into the right atrium RA.Once the catheter 1 reaches the anterior side of the inter-atrial septumIAS, the needle 2 advances so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. At this point, a guidewire replaces the needle 2 and the catheter 1is withdrawn. FIG. 1 also shows the tricuspid valve TV between the rightatrium RA and the right ventricle.

FIG. 2 illustrates a subsequent stage of a trans-septal approach inwhich guidewire 6 and guide catheter 4 pass through the inter-atrialseptum IAS. The guide catheter 4 provides access to the mitral valve forimplanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter passes through this puncture or incision directlyinto the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, antegradeapproaches will usually enable more precise and effective centering andstabilization of the guide catheter and/or prosthetic valve device. Theantegrade approach may also reduce the risk of damaging the chordaetendinae or other subvalvular structures with a catheter or otherinterventional tool. Additionally, the antegrade approach may decreaserisks associated with crossing the aortic valve as in retrogradeapproaches. This can be particularly relevant to patients withprosthetic aortic valves, which cannot be crossed at all or withoutsubstantial risk of damage.

FIGS. 3 and 4 show examples of a retrograde approaches to access themitral valve. Access to the mitral valve MV may be achieved from theaortic arch AA, across the aortic valve AV, and into the left ventricleLV below the mitral valve MV. The aortic arch AA may be accessed througha conventional femoral artery access route or through more directapproaches via the brachial artery, axillary artery, radial artery, orcarotid artery. Such access may be achieved with the use of a guidewire6. Once in place, a guide catheter 4 may be tracked over the guidewire6. Alternatively, a surgical approach may be taken through an incisionin the chest, preferably intercostally without removing ribs, andplacing a guide catheter through a puncture in the aorta itself. Theguide catheter 4 affords subsequent access to permit placement of theprosthetic valve device, as described in more detail herein. Retrogradeapproaches advantageously do not need a trans-septal puncture.Cardiologists also more commonly use retrograde approaches, and thusretrograde approaches are more familiar.

FIG. 5 shows a trans-apical approach via a trans-apical puncture. Inthis approach, access to the heart is via a thoracic incision, which canbe a conventional open thoracotomy or sternotomy, or a smallerintercostal or sub-xyphoid incision or puncture. An access cannula isthen placed through a puncture in the wall of the left ventricle at ornear the apex of the heart. The catheters and prosthetic devices of theinvention may then be introduced into the left ventricle through thisaccess cannula. The trans-apical approach provides a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalapproach does not require training in interventional cardiology toperform the catheterizations required in other percutaneous approaches.

Selected Embodiments of Delivery Systems for Prosthetic Heart ValveDevices

FIG. 6 is an isometric view of a hydraulic system 100 (“system 100”) fordelivering a prosthetic heart valve device configured in accordance withan embodiment of the present technology. The system 100 includes acatheter 102 having an elongated catheter body 108 (“catheter body 108”)and a delivery capsule 106. The catheter body 108 can include a proximalportion 108 a coupled to a hand held control unit 104 (“control unit104”) and a distal portion 108 b carrying the delivery capsule 106. Thedelivery capsule 106 can be configured to contain a prosthetic heartvalve device 110 (shown schematically in broken lines). The control unit104 can provide steering capability (e.g., 360 degree rotation of thedelivery capsule 106, 180 degree rotation of the delivery capsule 106,3-axis steering, 2-axis steering, etc.) used to deliver the deliverycapsule 106 to a target site (e.g., to a native mitral valve) and deploythe prosthetic heart valve device 110 at the target site. The catheter102 can be configured to travel over a guidewire 120, which can be usedto guide the delivery capsule 106 into the native heart valve. Thesystem 100 can also include a fluid assembly 112 configured to supplyfluid to and receive fluid from the catheter 102 to hydraulically movethe delivery capsule 106 and deploy the prosthetic heart valve device110.

The fluid assembly 112 includes a fluid source 114 and a fluid line 116fluidically coupling the fluid source 114 to the catheter 102. The fluidsource 114 may contain a flowable substance (e.g., water, saline, etc.)in one or more reservoirs. The fluid line 116 can include one or morehoses, tubes, or other components (e.g., connectors, valves, etc.)through which the flowable substance can pass from the fluid source 114to the catheter 102 and/or through which the flowable substance candrain from the catheter 102 to the fluid source 114. In otherembodiments, the fluid line 116 can deliver the flowable substance tothe catheter 102 from a first reservoir of the fluid source 114 anddrain the flowable substance from the catheter 102 to a separatereservoir. The fluid assembly 112 can also include one or morepressurization devices (e.g., a pump), fluid connectors, fittings,valves, and/or other fluidic components that facilitate moving the fluidto and/or from the fluid source 114. As explained in further detailbelow, the movement of the flowable substance to and from the fluidassembly 112 can be used to deploy the prosthetic heart valve device 110from the delivery capsule 106 and/or resheathe the prosthetic heartvalve device 110 after at least partial deployment.

In certain embodiments, the fluid assembly 112 may comprise a controller118 that controls the movement of fluid to and from the catheter 102.The controller 118 can include, without limitation, one or morecomputers, central processing units, processing devices,microprocessors, digital signal processors (DSPs), and/orapplication-specific integrated circuits (ASICs). To store information,for example, the controller 118 can include one or more storageelements, such as volatile memory, non-volatile memory, read-only memory(ROM), and/or random access memory (RAM). The stored information caninclude, pumping programs, patient information, and/or other executableprograms. The controller 118 can further include a manual input device(e.g., a keyboard, a touch screen, etc.) and/or an automated inputdevice (e.g., a computer, a data storage device, servers, network,etc.). In still other embodiments, the controller 118 may includedifferent features and/or have a different arrangement for controllingthe flow of fluid into and out of the fluid source 114.

The control unit 104 can include a control assembly 122 and a steeringmechanism 124. For example, the control assembly 122 can includerotational elements, such as a knob, that can be rotated to rotate thedelivery capsule 106 about its longitudinal axis 107. The controlassembly 122 can also include features that allow a clinician to controlthe hydraulic deployment mechanisms of the delivery capsule 106 and/orthe fluid assembly 112. For example, the control assembly 122 caninclude buttons, levers, and/or other actuators that initiateunsheathing and/or resheathing the prosthetic heart valve device 110.The steering mechanism 124 can be used to steer the catheter 102 throughthe anatomy by bending the distal portion 108 b of the catheter body 108about a transverse axis. In other embodiments, the control unit 104 mayinclude additional and/or different features that facilitate deliveringthe prosthetic heart valve device 110 to the target site.

The delivery capsule 106 includes a housing 126 configured to carry theprosthetic heart valve device 110 in the containment configuration and,optionally, an end cap 128 that extends distally from the housing 126and encloses the prosthetic heart valve device 110 in the housing 126.The end cap 128 can have an opening 130 at its distal end through whichthe guidewire 120 can be threaded to allow for guidewire delivery to thetarget site. As shown in FIG. 6, the end cap 128 can also have anatraumatic shape (e.g., a partially spherical shape, a frusto-conicalshape, blunt configuration, rounded configuration, etc.) to facilitateatraumatic delivery of the delivery capsule 106 to the target site. Incertain embodiments, the end cap 128 can also house a portion of theprosthetic heart valve device 110. The housing 126 and/or the end cap128 can be made of metal, polymers, plastic, composites, combinationsthereof, or other materials capable of holding the prosthetic heartvalve device 110. As discussed in further detail below, the deliverycapsule 106 is hydraulically driven via the control unit 104 and/or thefluid assembly 112 between a containment configuration for holding theprosthetic heart valve device 110 and a deployment configuration for atleast partially deploying the prosthetic heart valve device 110 at thetarget site. The delivery capsule 106 also allows for resheathing of theprosthetic heart valve device 110 after it has been partially deployed.

FIG. 7A is a partially schematic illustration of a distal portion of thesystem 100 of FIG. 6 in the containment configuration positioned in anative mitral valve of a heart using a trans-apical delivery approach inaccordance with embodiments of the present technology, and FIG. 7B is apartially schematic illustration of the system 100 in the deploymentconfiguration. Referring to FIG. 7A, a guide catheter 140 can bepositioned in a trans-apical opening 141 in the heart to provide accessto the left ventricle LV, and the catheter 102 can extend through theguide catheter 140 such that the distal portion 108 b of the catheterbody 108 projects beyond the distal end of the guide catheter 140. Thedelivery capsule 106 is then positioned between a posterior leaflet PLand an anterior leaflet AL of a mitral valve MV. Using the control unit104 (FIG. 6), the catheter body 108 can be moved in the superiordirection (as indicated by arrow 149), the inferior direction (asindicated by arrow 151), and/or rotated along the longitudinal axis ofthe catheter body 108 to position the delivery capsule 106 at a desiredlocation and orientation within the opening of the mitral valve MV.

Once at a target location, the delivery capsule 106 can be hydraulicallydriven from the containment configuration (FIG. 7A) towards thedeployment configuration (FIG. 7B) to partially or fully deploy theprosthetic heart valve device 110 from the delivery capsule 106. Forexample, as explained in further detail below, the delivery capsule 106can be hydraulically driven towards the deployment configuration bysupplying a flowable liquid to a chamber of the delivery capsule 106while also removing a flowable liquid from a separate chamber of thedelivery capsule 106. The hydraulically controlled movement of thedelivery capsule 106 is expected to reduce, limit, or substantiallyeliminate uncontrolled deployment of the prosthetic heart valve device110 caused by forces associated with expansion of the prosthetic heartvalve device 110, such as jumping, self-ejection, and/or other types ofuncontrolled movement. For example, the delivery capsule 106 is expectedto inhibit or prevent translation of the prosthetic heart valve device110 relative to the catheter body 108 while at least a portion of theprosthetic heart valve device 110 expands.

Referring to FIG. 7B, in trans-apical delivery approaches, theprosthetic heart valve device 110 is deployed from the delivery capsule106 by drawing the housing 126 proximally (i.e., further into the leftventricle LV) and, optionally, moving the end cap 128 distally (i.e.,further into the left atrium LA). As the prosthetic heart valve device110 exits the housing 126, the device 110 expands and presses againsttissue on an inner surface of the annulus of the mitral valve MV tosecure the device 110 in the mitral valve MV. The catheter 102 is alsoconfigured to partially or fully resheathe the prosthetic heart valvedevice 110 after partial deployment from the delivery capsule 106. Forexample, the delivery capsule 106 can be hydraulically driven backtowards the containment configuration by transferring fluid into onechamber of the delivery capsule 106 and removing fluid from anotherchamber of the delivery capsule 106 in an opposite manner as that usedfor deployment. This resheathing ability allows the clinician tore-position the prosthetic heart valve device 110, in vivo, forredeployment within the mitral valve MV or remove the prosthetic heartvalve device 110 from the patient after partial deployment. After fulldeployment of the prosthetic heart valve device 110, the end cap 128 canbe drawn through the deployed prosthetic heart valve device 110 to againclose the delivery capsule 106 and draw the catheter 102 proximallythrough the guide catheter 140 for removal from the patient. Afterremoving the catheter 102, it can be cleaned and used to deliveradditional prosthetic devices or it can be discarded.

FIGS. 8A and 8B are partially schematic cross-sectional views of thedelivery system 100 of FIG. 6 in the containment configuration (FIG. 8A)and the deployment configuration (FIG. 8B) in accordance with anembodiment of the present technology. As shown in FIGS. 8A and 8B, thedistal portion 108 b of the elongated catheter body 108 carries thedelivery capsule 106. The delivery capsule 106 includes the housing 126and a platform 142 that together define, at least in part, a firstchamber 144 a and a second chamber 144 b (referred to collectively as“the chambers 144”). The first chamber 144 a and the second chamber 144b are fluidically sealed from each other and from a compartment 146 inthe housing 126 that is configured to contain the prosthetic heart valvedevice 110. The chambers 144 can be filled and drained to hydraulicallydrive the delivery capsule 106 between the containment configuration(FIG. 8A) for holding the prosthetic heart valve device 110 and thedeployment configuration (FIG. 8B) for at least partially deploying theprosthetic heart valve device 100. As shown in FIG. 8A, for example, thehousing 126 of the delivery capsule 106 is urged proximally (in thedirection of arrow 153) towards the deployment configuration when fluidis at least partially drained from the first chamber 144 a (as indicatedby arrow 159) while fluid is being delivered to the second chamber 144 b(as indicated by arrow 157). The proximal translation of the housing 126allows the prosthetic heart valve device 110 to at least partiallydeploy from the housing 126 (FIG. 8B) and expand such that it may engagesurrounding tissue of a native mitral valve. As shown in FIG. 8B, thehousing 126 is urged distally back towards the containment configurationto resheathe at least a portion of the prosthetic heart valve device 110when fluid is at least partially drained from the second chamber 144 b(as indicated by arrow 161) while fluid is being delivered into thefirst chamber 144 b (as indicated by arrow 163).

The platform 142 extends at least partially between the inner wall ofthe housing 126 to divide the housing 126 into the first chamber 144 aand the second chamber 144 b. The platform 142 can be integrally formedas a part of the housing 126, such as an inwardly extending flange.Thus, the platform 142 can be made from the same material as the housing126 (e.g., metal, polymers, plastic, composites, combinations thereof,or other). In other embodiments, the platform 142 may be a separatecomponent that at least partially separates the two chambers 144 fromeach other.

As shown in FIGS. 8A and 8B, a fluid delivery shaft 148 (“shaft 148”)extends through the catheter body 108, into the housing 126 of thedelivery capsule 106, and through the platform 142. At its proximal end(not shown), the shaft 148 is coupled to a fluid source (e.g., the fluidsource 114 of FIG. 6) and includes one or more fluid lines 152(identified individually as a first line 152 a and a second line 152 b)that can deliver and/or drain fluid to and/or from the chambers 144. Thefluid lines 152 can be fluid passageways or lumens integrally formedwithin the shaft 148, such as channels through the shaft itself, or thefluid lines 152 may be tubes or hoses positioned within one or morehollow regions of the shaft 148. The first line 152 a is in fluidcommunication with the first chamber 144 a via a first opening 166 a inthe first fluid line 152 a, and the second line 152 b is in fluidcommunication with the second chamber 144 b via a second opening 166 bin the second fluid line 152 b. In other embodiments, the first andsecond chambers 144 a and 144 b can be in fluid communication with morethan one fluid line. For example, each chamber 144 may have a dedicatedfluid delivery line and dedicated fluid drain line.

The shaft 148 can also include a first flange or pedestal 154 a and asecond flange or pedestal 154 b (referred to together as “flanges 154”)that extend outwardly from the shaft 148 to define the proximal anddistal ends of the first and second chambers 144 a and 144 b,respectively. Accordingly, the first chamber 144 a is defined at adistal end by a proximal-facing surface of the platform 142, at aproximal end by a distally-facing surface of the first flange 154 a, andby the interior wall of the housing 126 extending therebetween. Thesecond chamber 144 b is defined at a proximal end by a distal-facingsurface of the platform 142, at a distal end by a proximally-facingsurface of the second flange 154 b, and by the interior wall of thehousing 126 extending therebetween. The compartment 146 containing theprosthetic heart valve device 110 can be defined by a distal-facingsurface of the second flange 154 b, the end cap 128, and the interiorwall of the housing 126 extending therebetween. The shaft 148 and theflanges 154 can be integrally formed or separate components, and can bemade from metal, polymers, plastic, composites, combinations thereof,and/or other suitable materials for containing fluids. The flanges 148are fixed with respect to the shaft 148. Sealing members 156 (identifiedindividually as first through third sealing members 156 a-c,respectively), such as O-rings, can be positioned around or within theflanges 154 and/or the platform 142 to fluidically seal the chambers 144from other portions of the delivery capsule 106. For example, the firstand second sealing members 156 a and 156 b can be positioned in recessesof the corresponding first and second flanges 154 a and 154 b tofluidically seal the flanges 154 against the interior wall of thehousing 126, and the third sealing member 156 c can be positioned withina recess of the platform 142 to fluidically seal the platform 142 to theshaft 148. In other embodiments, the system 100 can include additionaland/or differently arranged sealing members to fluidically seal thechambers 144.

The fluid lines 152 are in fluid communication with a manifold 158 at aproximal portion of the system 100 and in communication with the fluidassembly 112 (FIG. 6). The manifold 158 may be carried by the controlunit 104 (FIG. 6) or it may be integrated with the fluid assembly 112(FIG. 6). As shown in FIGS. 8A and 8B, the manifold 158 can include afluid delivery lumen 160 that bifurcates to allow for delivery of fluidto the first and second fluid lines 152 a and 152 b and a drain lumen162 that bifurcates to allow for removal of fluid from the first andsecond fluid lines 152 a and 152 b. The delivery lumen 160 and the drainlumen 162 can be placed in fluid communication with the fluid source 114(FIG. 6) to allow fluid to move between the fluid source 114 to thechambers 144. In other embodiments, each fluid line 152 can have adedicated delivery lumen and a dedicated drain lumen, which are in turnfluidly coupled to separate fluid reservoirs in the fluid source 114(FIG. 6).

The manifold 158 further includes one or more valves 164 (referred toindividually as a first valve 164 a and a second valve 164 b) thatregulate fluid flow to and from the chambers 144. The first valve 164 ais in fluid communication with the first fluid line 152 a, the deliverylumen 160 (or a portion thereof), and the drain line 162 (or a portionthereof) to regulate fluid to and from the first chamber 144 a. Thesecond valve 164 b is in fluid communication with the second fluid line152 b, the delivery lumen 160 (or a portion thereof), and the drain line162 (or a portion thereof) to regulate fluid to and from the secondchamber 144 b. The valves 164 can be three-way valves and/or othersuitable valves for regulating fluid to and from the fluid lines 152.

As shown in FIG. 8A, in the initial containment configuration, the firstchamber 144 a is at least partially filled with fluid and the secondchamber 144 b includes little to no fluid. To fully or partiallyunsheathe the prosthetic heart valve device 110, the second valve 164 bopens the second fluid line 152 b and closes the drain line 162. Thisallows fluid to flow from the delivery lumen 160, through the secondfluid line 152 b, and into the second chamber 144 b via the secondopening 166 b (as indicated by arrows 157), while simultaneouslyblocking fluid from draining into the drain line 162. As fluid isdelivered to the second chamber 144 b, fluid also drains from the firstchamber 144 a. To do this, the first valve 164 a closes the first line152 a proximal to the first valve 164 a (i.e., such that the first line152 a is not in fluid communication with the delivery lumen 160) andopens the drain lumen 162 so that fluid exits the first chamber 144 avia the first opening 166 a, travels along the first fluid line 152 a,and into the drain lumen 162 via the first valve 164 a (as indicated byarrows 159). In certain embodiments, fluid is transferred to the secondchamber 144 b and from the first chamber 144 a simultaneously and,optionally, in equal quantities so that the same amount of fluidtransferred out of the first chamber 144 a is transferred into thesecond chamber 144 b. In other embodiments, different amounts of fluidare drained from and transferred to the chambers 144. This concurrenttransfer of fluid into the second chamber 144 b while draining fluidfrom the first chamber 144 a drives the housing 126 proximally in thedirection of arrow 153, which unsheathes the prosthetic heart valvedevice 110 and allows it to at least partially expand. As shown in FIG.8B, this proximal movement of the housing 126 creates an open chamber170 defined by the distal facing surface of the housing 126 and theproximal-facing surface of the flange 154 a.

As shown in FIG. 8B, during deployment of the prosthetic heart valvedevice 110, the delivery capsule 106 axially restrains an outflowportion of the prosthetic heart valve device 110 while an inflow portionof the prosthetic heart valve device 110 is deployed from the deliverycapsule 106. After at least partial deployment, the fluid chambers 144can be pressurized and drained in an inverse manner to move the housing126 distally (in the direction of arrow 155) back toward the containmentconfiguration and at least partially resheathe the prosthetic heartvalve device 110. For resheathing, the second valve 164 b is placed influid communication with the drain lumen 162 and closes the second fluidline 152 b proximal to the second valve 164 b so that fluid drains fromthe second chamber 144 b via the second opening 166 b, through thesecond fluid line 152 b, and into the drain lumen 162 (as indicated byarrows 161). As fluid exits the second chamber 144 b, fluid is alsodelivered to the first chamber 144 a. That is, the first valve 164 a isplaced in fluid communication with the delivery lumen 160 to deliverfluid into the first chamber 144 a via the first opening 166 a of thefirst fluid line 152 a (as indicated by arrows 163). Again, the fluidcan be transferred simultaneously and/or in equal proportions from thesecond chamber 144 b and to the first chamber 144 a. This transfer offluid into the first chamber 144 a and from the second chamber 144 bdrives the housing 126 distally in the direction of arrow 155 tocontrollably resheathe the prosthetic heart valve device 110 such thatat least a portion of the prosthetic heart valve device 110 is againpositioned within the compartment 146. This partial or full resheathingof the prosthetic heart valve device 110 allows a clinician toreposition or remove the prosthetic heart valve device 110 after partialdeployment. The hydraulic movement of the housing 126 is expected toprovide controlled deployment and resheathing of the prosthetic heartvalve device 110.

As the delivery capsule 106 moves between the containment configurationand the deployment configuration, the housing 126 moves slideably withrespect to the longitudinal axis of the shaft 148, while the prostheticheart valve device 110 at least substantially maintains its longitudinalposition relative to the catheter body 108. That is, the deliverycapsule 106 can substantially prevent longitudinal translation of theprosthetic heart valve device 110 relative to the catheter body 108while the prosthetic heart valve device 110 moves between thecontainment configuration (FIG. 8A) and the deployment configuration(FIG. 8B). This allows the clinician to position the sheathed prostheticheart valve device 110 at the desired target site for deployment, andthen deploy the device 110 at that target site without needing tocompensate for any axial movement of the device 110 as it reaches fullexpansion (e.g., as would need to be taken into account if the device110 was pushed distally from the housing 126).

As further shown in FIGS. 8A and 8B, the system 100 may also include abiasing device 168 that acts on the housing 126 to urge the housing 126toward the containment configuration. The biasing device 168 compressesas the housing 126 moves to the deployment configuration (FIG. 8B) toapply more force on the housing 126 in a distal direction toward thecontainment configuration. In certain embodiments, the biasing device168 acts continuously on the housing 126 urging it toward thecontainment configuration, and in other embodiments the biasing device168 only acts on the housing 126 as it is compressed during deployment.In the illustrated embodiment, the biasing device 168 is a spring, butin other embodiments the biasing device can include other features thaturge the housing 126 toward the containment configuration. The biasingdevice 168 limits or substantially prevents opening of the deliverycapsule 106 attributable to the forces produced by the expandingprosthetic heart valve device 110. For example, an unsheathed portion ofthe prosthetic heart valve device 110 can expand outwardly from thepartially opened delivery capsule 106 while the biasing device 168inhibits further opening of the delivery capsule 106.

The system 100 shown in FIGS. 8A and 8B allows for delivery of theprosthetic heart valve device 110 to a mitral valve from the leftventricle (e.g., via a trans-apical approach shown in FIGS. 7A and 7B).For example, the hydraulic delivery mechanism moves the housing 126proximally toward the distal portion 108 b of the catheter body 108 todeploy the prosthetic heart valve device 110 (e.g., as shown in FIG.7A), and once the prosthetic heart valve device 110 is fully deployed,the end cap 128 can be moved proximally from the left atrium and intothe left ventricle through the deployed device 110.

FIGS. 9A and 9B are side cross-sectional views of a distal portion of adelivery system 200 for a prosthetic heart valve device 110 in aretained state (FIG. 9A) and in a fully deployed state (FIG. 9B) inaccordance with another embodiment of the present technology. Thedelivery system 200 can include various features at least generallysimilar to the features of the system 100 described above with referenceto FIGS. 6-8B. For example, the delivery system 200 can be hydraulicallydriven by moving fluid to and from two separate chambers 144 (only thesecond chamber 144 b shown in FIGS. 9A and 9B) to move the housing 126between deployment and containment configurations. The delivery system200 also includes the fluid delivery shaft 148 with flanges 154 thatdefine the outer bounds of the chambers 144.

The delivery system 200 of FIGS. 9A and 9B further includes anengagement device 272 that is configured to maintain engagement betweenthe delivery capsule 106 and the prosthetic heart valve device 110 afterthe prosthetic heart valve device 110 has been at least partiallyexpanded. The engagement device 272 includes a shaft 274 that extendsthrough (e.g., coaxially within) or alongside at least a portion of thefluid delivery shaft 148 and is controllable by a clinician from aproximal portion of the delivery system 200 (e.g., via the control unit104 of FIG. 6). The shaft 274 can be a central or engagement shaft thatincludes a distal region 273 having a pedestal 276 with one or moreengagement or attachment elements 278 that releasably mate withcorresponding attachment features 280 extending from the outflow regionof the prosthetic heart valve device 110.

The attachment elements 278 can be recesses or pockets that retaincorrespondingly shaped attachment features 280 (e.g., pins orprojections) on an outflow region of the prosthetic heart valve device110. For example, the attachment elements 278 can be circular pocketsthat receive eyelet-shaped attachment features 280 extending from theoutflow region of the prosthetic heart valve device 110 and/or theattachment elements 278 can be T-shaped recesses that receivecorresponding T-shaped attachment features 280 extending from theoutflow region of the prosthetic heart valve device 110.

FIG. 9C is a top view of the pedestal 276 illustrating one arrangementof the attachment elements 278. The illustrated pedestal 276 includesfour T-shaped recesses 281 spaced 90° apart from each other around theperiphery of the pedestal 276 and circular pockets 283 spaced betweenthe T-shaped recesses 281. The T-shaped recesses 281 may extend deeperinto the pedestal 276 than the circular pockets 283 (e.g., as shown inFIGS. 9A and 9B), or the attachment elements 278 can have similardepths. In other embodiments, the pedestal 276 has different quantitiesand/or arrangements of T-shaped recesses 281 and/or the circular pockets283 across the face of the pedestal 276. In further embodiments, thepedestal 276 can include differently shaped recesses and pockets thatreleasably mate with correspondingly-shaped attachment features on theprosthetic heart valve device 110. In still further embodiments, theengagement device 272 includes other features that releasably attach theprosthetic heart valve device 110 to the delivery system 200 beforefinal release from the delivery system 200.

In the embodiment illustrated in FIGS. 9A and 9B, the second flange 154b includes a projection 282 that forms a recess 284 facing theprosthetic heart valve device 110, and the recess 284 at least partiallyreceives the pedestal 276 to retain the attachment features 280 with theattachment elements 278. The projection 282 may extend toward theprosthetic heart valve device 110 beyond the surface of the pedestal 276positioned therein such that the projection 282 at least partiallyconstrains an end region of the prosthetic heart valve device 110 beforefull deployment. In other embodiments, the second flange 154 b does notinclude the projection 282, and the pedestal 276 abuts an end surface ofthe second flange 154 b and/or other outward-facing feature of thedelivery capsule 106.

In operation, a clinician moves the delivery capsule 106 to the targetsite (e.g., in a native mitral valve) and hydraulically moves thehousing 126 to unsheathe and at least partially expand the prostheticheart valve device 110. When the prosthetic heart valve device 110 issubstantially expanded (FIG. 9A), the engagement device 272 holds theprosthetic heart valve device 110 to the delivery system 200 in case thedevice 110 needs to be resheathed for repositioning or redeployment.This allows the clinician to again partially or fully resheathe theprosthetic heart valve device 110 to adjust its position or orientationwith respect to the native valve. Referring to FIG. 9B, after theprosthetic heart valve device 110 is partially deployed at theappropriate location, the clinician can move the engagement shaft 274 inthe direction of arrow 285 away from the remainder of the deliverycapsule 106 and out of the recess 284 (e.g., in a distal direction whendeployed trans-apically). This movement releases the mateably receivedattachment features 280 on the prosthetic heart valve device 110 fromthe corresponding attachment elements 278 to fully release theprosthetic heart valve device 110 from the delivery system 200. Forexample, the expansion of the previously restrained proximal-mostportion of the prosthetic heart valve device 110 (e.g., restrained bythe projection 282 of the flange 154 b) results in a force thatdisengages the attachment features 280 from the attachment elements 278and allows the device 110 to fully expand. In other embodiments, theengagement shaft 274 can remain stationary with respect to theprosthetic heart valve device 110 and the delivery capsule 106 (e.g.,the housing 126, the flange 154 b, etc.) can be moved away from theprosthetic heart valve device 110 (e.g., in a proximal direction whenthe device is deployed trans-apically) to disengage the attachmentfeatures 280 from the attachment elements 278.

FIGS. 10A-10C are a series of partially schematic illustrations of adistal portion of a hydraulic delivery system 300 deploying a prosthetica prosthetic heart valve device 310 within a native mitral valve of aheart using a trans-septal approach in accordance with furtherembodiments of the present technology. The hydraulic delivery system 300can include certain features generally similar the delivery systems 100,200 described above with reference to FIGS. 6-9C. For example, thedelivery system 300 includes a catheter 302 having an elongated catheterbody 308 and a delivery capsule 306 at a distal portion 308 b of thecatheter body 308. The proximal portion of the catheter 302 can becoupled to a fluid system (e.g., the fluid assembly 112 of FIG. 6)and/or a manifold (e.g., the manifold 158 of FIGS. 8A and 8B) tohydraulically move the delivery capsule 306 between a containmentconfiguration and a deployment configuration. The delivery system 300facilitates trans-septal delivery of the prosthetic heart valve device310 to the native mitral valve MV.

Referring to FIG. 10A, a puncture or opening 341 can be formed in anatrial region of a septum of the heart to access the left atrium LA. Aguide catheter 340 can be positioned through the opening 341, and aguidewire 320 can extend through the guide catheter 340, through themitral valve MV, and into the left ventricle LV. A delivery capsule 306at a distal portion 308 b of the elongated catheter body 308 can then bedelivered to the left atrium LA from the guide catheter 340, advancedalong the guidewire 320, and positioned at a target site between theposterior and anterior leaflets PL and AL of the mitral valve MV.

As shown in FIG. 10B, once at the target site in the mitral valve MV,the prosthetic heart valve device 310 can be deployed by removing aproximally positioned end cap 328 and moving a housing 326 of thedelivery capsule 306 in a distal direction (i.e., downstream furtherinto the left ventricle LV). In certain embodiments, fluid can bedelivered and removed to/from chambers (not shown) of the deliverycapsule 306 to hydraulically move the housing 326 toward the deploymentconfiguration. This distal movement unsheathes the upstream or inflowportion of the prosthetic heart valve device 310 while the downstream orventricular end of the prosthetic heart valve device 310 remainsconstrained within the housing 326. The unsheathed inflow portion canexpand outward to contact tissue of the mitral valve MV. If theclinician elects to adjust the positioning of the prosthetic heart valvedevice 310, fluid can be delivered to and removed from the deliverycapsule chambers in an opposite manner to hydraulically move the housing326 toward the containment configuration and at least partiallyresheathe the prosthetic heart valve device 310. After the deployedinflow portion of the prosthetic heart valve device 310 is appropriatelyseated in the mitral valve MV, fluid can again be delivered to andremoved from the delivery capsule chambers to again move the housing 326distally toward the deployment configuration. As shown in FIG. 10C,fluid can be delivered/removed until the housing 326 fully unsheathesthe prosthetic heart valve device 310 and the prosthetic heart valvedevice 310 expands against the mitral valve MV. In the fully deployedstate, the delivery capsule 306 can then be returned to the containmentconfiguration (e.g., with the housing 326 and the end cap 328 joinedtogether), pulled through the left atrium LA, and removed from theheart.

In other embodiments, the system 100 of FIGS. 6-8B can be reconfiguredto allow for deployment from the left atrium (e.g., via the trans-septalapproach shown in FIGS. 10A-10C) in which case the housing 126 with thefirst and second chambers 144 a and 144 b has the opposite orientationshown in FIGS. 8A and 8B. That is, the end cap 128 is positionedadjacent to the distal portion 108 b of the catheter body 108 and thehousing 126 is located distally from the end cap 128 with the shaft 148extending through or adjacent to the device 110 to allow fluid deliveryto the chambers 144. To deploy the prosthetic heart valve device 110,fluid is removed from the first fluid chamber 144 a while fluid isdelivered to the second fluid chamber 144 b, which moves the housing 126distally (further into the left ventricle) to at least partiallyunsheathe the prosthetic heart valve device 110. To resheathe theprosthetic heart valve device 110, fluid is removed from the secondfluid chamber 144 b while fluid is delivered to the first fluid chamber144 a, moving the housing 126 proximally (toward the catheter body 108)toward the containment configuration.

FIGS. 11A and 11B are enlarged, partially schematic cross-sectionalviews of a distal portion of the trans-septal delivery system 300 in apartially expanded deployment configuration (FIG. 11A) and a resheathingor containment configuration (FIG. 11B) in accordance with an embodimentof the present technology. As discussed above, the delivery system 300includes the delivery capsule 306 coupled to the distal portion 308 b ofthe catheter body 308. The delivery capsule 306 includes the housing 326and a platform 342 that define, at least in part, a first or deploymentchamber 344 a. The delivery system 300 further includes expandablemember 390 coupled to the catheter body 308 and distal to the deliverycapsule 306. The interior of the expandable member 390 defines a secondor resheathing chamber 344 b. The expandable member 390 can be a balloonor other expandable component in which a fluid can be contained andremoved. The delivery system 300 can also include sealing features 356(identified individually as a first sealing features 356 a and a secondsealing feature 356 b), such as O-rings, to fluidically seal thedeployment chamber 344 a from a containment compartment 346 (FIG. 11B)in the housing 326 that carries the prosthetic heart valve device 310and the expandable member 390. In other embodiments, the delivery system300 can include additional sealing features for fluidically sealing thedeployment chamber 344 a and the resheathing chamber 344 b.

As further shown in FIGS. 11A and 11B, a fluid delivery shaft 348extends through the housing 326 and into the expandable member 390. Thefluid delivery shaft 348 includes at least a first fluid line 352 a influid communication with the deployment chamber 344 a via a firstopening 366 a and a second fluid line 352 b in fluid communication withthe resheathing chamber 344 b via a second opening 366 b. The proximalportions of the fluid lines 352 can be in fluid communication with amanifold (not shown; e.g., the manifold 158 of FIGS. 8A and 8B) and/or afluid system (not shown; e.g., the fluid assembly 112 of FIG. 6) toallow fluid to be delivered to and removed from the deployment andresheathing chambers 344 a and 344 b. In other embodiments, the firstfluid line 352 a and the second fluid line 352 b can be separatecomponents, such as two fluid delivery/removal shafts, one in fluidcommunication with the deployment chamber 344 a and one in fluidcommunication with the resheathing chamber 344 b. The fluid deliveryshaft 348 can extend through the catheter body 308, adjacent to thecatheter body 308. In other embodiments, the fluid delivery shaft 348 isomitted and the fluid lines 352 can be separate components that extendthrough the catheter body 308.

In various embodiments, the delivery system 300 can further include adistal end cap 392 positioned distal to the expandable member 390 andcoupled to the distal portion 308 b of the catheter body 308 and/or thefluid delivery shaft 348. The distal end cap 392 can be configured toseal the distal end of the expandable member 390 and/or may have anatraumatic shape (e.g., frusto-conical, partially spherical, etc.) tofacilitate atraumatic delivery of the delivery capsule 306 to the targetsite. As shown in FIGS. 11A and 11B, the distal end cap 392 can alsoinclude an opening 330 that allows for guidewire delivery of thedelivery capsule 306 to the target site.

The delivery capsule 306 can be hydraulically driven between acontainment configuration in which the prosthetic heart valve device 310is held in the compartment 346 of the housing 326 and the deploymentconfiguration in which at least a portion of the prosthetic heart valvedevice 310 expands from the compartment 346. More specifically, in aninitial containment state (e.g., as the delivery capsule 306 isdelivered to the target site), the prosthetic heart valve device 310 isheld in the compartment 346 of the housing 326 and the expandable member390 is at least substantially empty (e.g., the configuration of theexpandable member 390 shown in FIG. 11A). To begin deployment, fluid isdelivered to the deployment chamber 344 a via the first line 352 a(e.g., as indicated by arrows 391 in FIG. 11A). Providing fluid to thedeployment chamber 344 a increases the pressure therein, thereby movingthe housing 326 distally relative to the platform 342 and unsheathingthe prosthetic heart valve device 310 (beginning with the atrial orinflow portion of the device 310). This unsheathing mechanism at leastsubstantially prevents translation of the prosthetic heart valve device310 relative to the catheter body 308 and the surrounding anatomy tofacilitate positioning and deployment of the device 310.

As shown in FIG. 11B, the prosthetic heart valve device 310 can be atleast partially resheathed after at least partial deployment. Toresheathe the device 310, fluid is drained or removed from deploymentchamber 344 a (as indicated by arrows 393), while fluid is delivered tothe expandable member 390 via the second line 352 b (as indicated byarrows 395). The expansion of the expandable member 390 urges thehousing 326 towards the containment configuration such that theprosthetic heart valve device 310 is at least partially resheathed andagain positioned at least partially in the compartment 346 of thehousing 326 (FIG. 11B). Accordingly, the delivery system 300 providesfor controlled, hydraulic delivery of the prosthetic heart valve device310 via a trans-septal delivery approach and also inhibits translationof the prosthetic heart valve device 310 during deployment andresheathing to facilitate accurate delivery to the target site.

Selected Embodiments of Prosthetic Heart Valve Devices

The hydraulic delivery systems 100, 200, 300 described above withreference to FIGS. 6-11B can be configured to deliver various prostheticheart valve devices, such as prosthetic valve devices for replacement ofthe mitral valve and/or other valves (e.g., a bicuspid or tricuspidvalve) in the heart of the patient. Examples of these prosthetic heartvalve devices, system components, and associated methods are describedin this section with reference to FIGS. 12A-25. Specific elements,substructures, advantages, uses, and/or other features of theembodiments described with reference to FIGS. 12A-25 can be suitablyinterchanged, substituted or otherwise configured with one another.Furthermore, suitable elements of the embodiments described withreference to FIGS. 12A-25 can be used as stand-alone and/orself-contained devices.

FIG. 12A is a side cross-sectional view and FIG. 12B is a top plan viewof a prosthetic heart valve device (“device”) 1100 in accordance with anembodiment of the present technology. The device 1100 includes a valvesupport 1110, an anchoring member 1120 attached to the valve support1110, and a prosthetic valve assembly 1150 within the valve support1110. Referring to FIG. 12A, the valve support 1110 has an inflow region1112 and an outflow region 1114. The prosthetic valve assembly 1150 isarranged within the valve support 1110 to allow blood to flow from theinflow region 1112 through the outflow region 1114 (arrows BF), butprevent blood from flowing in a direction from the outflow region 1114through the inflow region 1112.

In the embodiment shown in FIG. 12A, the anchoring member 1120 includesa base 1122 attached to the outflow region 1114 of the valve support1110 and a plurality of arms 1124 projecting laterally outward from thebase 1122. The anchoring member 1120 also includes a fixation structure1130 extending from the arms 1124. The fixation structure 1130 caninclude a first portion 1132 and a second portion 1134. The firstportion 1132 of the fixation structure 1130, for example, can be anupstream region of the fixation structure 1130 that, in a deployedconfiguration as shown in FIG. 12A, is spaced laterally outward apartfrom the inflow region 1112 of the valve support 1110 by a gap G. Thesecond portion 1134 of the fixation structure 1130 can be adownstream-most portion of the fixation structure 1130. The fixationstructure 1130 can be a cylindrical ring (e.g., straight cylinder orconical), and the outer surface of the fixation structure 1130 candefine an annular engagement surface configured to press outwardlyagainst a native annulus of a heart valve (e.g., a mitral valve). Thefixation structure 1130 can further include a plurality of fixationelements 1136 that project radially outward and are inclined toward anupstream direction. The fixation elements 1136, for example, can bebarbs, hooks, or other elements that are inclined only in the upstreamdirection (e.g., a direction extending away from the downstream portionof the device 1100).

Referring still to FIG. 12A, the anchoring member 1120 has a smooth bend1140 between the arms 1124 and the fixation structure 1130. For example,the second portion 1134 of the fixation structure 1130 extends from thearms 1124 at the smooth bend 1140. The arms 1124 and the fixationstructure 1130 can be formed integrally from a continuous strut orsupport element such that the smooth bend 1140 is a bent portion of thecontinuous strut. In other embodiments, the smooth bend 1140 can be aseparate component with respect to either the arms 1124 or the fixationstructure 1130. For example, the smooth bend 1140 can be attached to thearms 1124 and/or the fixation structure 1130 using a weld, adhesive orother technique that forms a smooth connection. The smooth bend 1140 isconfigured such that the device 1100 can be recaptured in a capsule orother container after the device 1100 has been at least partiallydeployed.

The device 1100 can further include a first sealing member 1162 on thevalve support 1110 and a second sealing member 1164 on the anchoringmember 1120. The first and second sealing members 1162, 1164 can be madefrom a flexible material, such as Dacron® or another type of polymericmaterial. The first sealing member 1162 can cover the interior and/orexterior surfaces of the valve support 1110. In the embodimentillustrated in FIG. 12A, the first sealing member 1162 is attached tothe interior surface of the valve support 1110, and the prosthetic valveassembly 1150 is attached to the first sealing member 1162 andcommissure portions of the valve support 1110. The second sealing member1164 is attached to the inner surface of the anchoring member 1120. As aresult, the outer annular engagement surface of the fixation structure1130 is not covered by the second sealing member 1164 so that the outerannular engagement surface of the fixation structure 1130 directlycontacts the tissue of the native annulus.

The device 1100 can further include an extension member 1170. Theextension member 1170 can be an extension of the second sealing member1164, or it can be a separate component attached to the second sealingmember 1164 and/or the first portion 1132 of the fixation structure1130. The extension member 1170 can be a flexible member that, in adeployed state (FIG. 12A), flexes relative to the first portion 1132 ofthe fixation structure 1130. In operation, the extension member 1170provides tactile feedback or a visual indicator (e.g., onechocardiographic or fluoroscopic imaging systems) to guide the device1100 during implantation such that the device 1100 is located at adesired elevation and centered relative to the native annulus. Asdescribed below, the extension member 1170 can include a support member,such as a metal wire or other structure, that can be visualized viafluoroscopy or other imaging techniques during implantation. Forexample, the support member can be a radiopaque wire.

FIGS. 13A and 13B are cross-sectional views illustrating an example ofthe operation of the smooth bend 1140 between the arms 1124 and thefixation structure 1130 in the recapturing of the device 1100 afterpartial deployment. FIG. 13A schematically shows the device 1100 loadedinto a capsule 1700 of a delivery system in a delivery state, and FIG.13B schematically shows the device 1100 in a partially deployed state.Referring to FIG. 13A, the capsule 1700 has a housing 1702, a pedestalor support 1704, and a top 1706. In the delivery state shown in FIG.13A, the device 1100 is in a low-profile configuration suitable fordelivery through a catheter or cannula to a target implant site at anative heart valve.

Referring to FIG. 13B, the housing 1702 of the capsule 1700 has beenmoved distally such that the extension member 1170, fixation structure1130 and a portion of the arms 1124 have been released from the housing1702 in a partially deployed state. This is useful for locating thefixation structure 1130 at the proper elevation relative to the nativevalve annulus A such that the fixation structure 1130 expands radiallyoutward into contact the inner surface of the native annulus A. However,the device 1100 may need to be repositioned and/or removed from thepatient after being partially deployed. To do this, the housing 1702 isretracted (arrow R) back toward the fixation structure 1130. As thehousing 1702 slides along the arms 1124, the smooth bend 1140 betweenthe arms 1124 and the fixation structure 1130 allows the edge 1708 ofthe housing 1702 to slide over the smooth bend 1140 and therebyrecapture the fixation structure 1130 and the extension member 1170within the housing 1702. The device 1100 can then be removed from thepatient or repositioned for redeployment at a better location relativeto the native annulus A. Further aspects of prosthetic heart valvedevices in accordance with the present technology and their interactionwith corresponding delivery devices are described below with referenceto FIGS. 14-25.

FIG. 14 is a top isometric view of an example of the device 1100. Inthis embodiment, the valve support 1110 defines a first frame (e.g., aninner frame) and fixation structure 1130 of the anchoring member 1120defines a second frame (e.g., an outer frame) that each include aplurality of structural elements. The fixation structure 1130, morespecifically, includes structural elements 1137 arranged indiamond-shaped cells 1138 that together form at least a substantiallycylindrical ring when freely and fully expanded as shown in FIG. 14. Thestructural elements 1137 can be struts or other structural featuresformed from metal, polymers, or other suitable materials that canself-expand or be expanded by a balloon or other type of mechanicalexpander.

In several embodiments, the fixation structure 1130 can be a generallycylindrical fixation ring having an outwardly facing engagement surface.For example, in the embodiment shown in FIG. 14, the outer surfaces ofthe structural elements 1137 define an annular engagement surfaceconfigured to press outwardly against the native annulus in the deployedstate. In a fully expanded state without any restrictions, the walls ofthe fixation structure 1130 are at least substantially parallel to thoseof the valve support 1110. However, the fixation structure 1130 can flexinwardly (arrow I) in the deployed state when it presses radiallyoutwardly against the inner surface of the native annulus of a heartvalve.

The embodiment of the device 1100 shown in FIG. 14 includes the firstsealing member 1162 lining the interior surface of the valve support1110, and the second sealing member 1164 along the inner surface of thefixation structure 1130. The extension member 1170 has a flexible web1172 (e.g., a fabric) and a support member 1174 (e.g., metal orpolymeric strands) attached to the flexible web 1172. The flexible web1172 can extend from the second sealing member 1164 without ametal-to-metal connection between the fixation structure 1130 and thesupport member 1174. For example, the extension member 1170 can be acontinuation of the material of the second sealing member 1164. Severalembodiments of the extension member 1170 are thus a malleable or floppystructure that can readily flex with respect to the fixation structure1130. The support member 1174 can have a variety of configurations andbe made from a variety of materials, such as a double-serpentinestructure made from Nitinol.

FIG. 15 is a side view and FIG. 16 is a bottom isometric view of thedevice 1100 shown in FIG. 14. Referring to FIG. 15, the arms 1124 extendradially outward from the base portion 1122 at an angle α selected toposition the fixation structure 1130 radially outward from the valvesupport 1110 (FIG. 14) by a desired distance in a deployed state. Theangle α is also selected to allow the edge 1708 of the delivery systemhousing 1702 (FIG. 13B) to slide from the base portion 1122 toward thefixation structure 1130 during recapture. In many embodiments, the angleα is 15°-75°, or more specifically 15°-60°, or still more specifically30°-45°. The arms 1124 and the structural elements 1137 of the fixationstructure 1130 can be formed from the same struts (i.e., formedintegrally with each other) such that the smooth bend 1140 is acontinuous, smooth transition from the arms 1124 to the structuralelements 1137. This is expected to enable the edge 1708 of the housing1702 to more readily slide over the smooth bend 1140 in a manner thatallows the fixation structure 1130 to be recaptured in the housing 1702of the capsule 1700 (FIG. 13B). Additionally, by integrally forming thearms 1124 and the structural elements 1137 with each other, it inhibitsdamage to the device 1100 at a junction between the arms 1124 and thestructural elements 1137 compared to a configuration in which the arms1124 and structural elements 1137 are separate components and welded orotherwise fastened to each other.

Referring to FIGS. 15 and 16, the arms 1124 are also separated from eachother along their entire length from where they are connected to thebase portion 1122 through the smooth bend 1140 (FIG. 15) to thestructural elements 1137 of the fixation structure 1130. The individualarms 1124 are thus able to readily flex as the edge 1708 of the housing1702 (FIG. 13B) slides along the arms 1124 during recapture. This isexpected to reduce the likelihood that the edge 1708 of the housing 1702will catch on the arms 1124 and prevent the device 1100 from beingrecaptured in the housing 1702.

In one embodiment, the arms 1124 have a first length from the base 1122to the smooth bend 1140, and the structural elements 1137 of thefixation structure 1130 at each side of a cell 1138 (FIG. 14) have asecond length that is less than the first length of the arms 1124. Thefixation structure 1130 is accordingly less flexible than the arms 1124.As a result, the fixation structure 1130 is able to press outwardlyagainst the native annulus with sufficient force to secure the device1100 to the native annulus, while the arms 1124 are sufficientlyflexible to fold inwardly when the device is recaptured in a deliverydevice.

In the embodiment illustrated in FIGS. 14-16, the arms 1124 and thestructural elements 1137 are configured such that each arm 1124 and thetwo structural elements 1137 extending from each arm 1124 formed aY-shaped portion 1142 (FIG. 16) of the anchoring member 1120.Additionally, the right-hand structural element 1137 of each Y-shapedportion 1142 is coupled directly to a left-hand structural element 1137of an immediately adjacent Y-shaped portion 1142. The Y-shaped portions1142 and the smooth bends 1140 are expected to further enhance theability to slide the housing 1702 along the arms 1124 and the fixationstructure 1130 during recapture.

FIG. 17 is a side view and FIG. 18 is a bottom isometric view of aprosthetic heart valve device (“device”) 1200 in accordance with anotherembodiment of the present technology. The device 1200 is shown withoutthe extension member 1170 (FIGS. 14-16), but the device 1200 can furtherinclude the extension member 1170 described above. The device 1200further includes extended connectors 1210 projecting from the base 1122of the anchoring member 1120. Alternatively, the extended connectors1210 can extend from the valve support 1110 (FIGS. 12A-16) in additionto or in lieu of extending from the base 1122 of the anchoring member1120. The extended connectors 1210 can include a first strut 1212 aattached to one portion of the base 1122 and a second strut 1212 battached to another portion of the base 1122. The first and secondstruts 1212 a-b are configured to form a V-shaped structure in whichthey extend toward each other in a downstream direction and areconnected to each other at the bottom of the V-shaped structure. TheV-shaped structure of the first and second struts 1212 a-b causes theextension connector 1210 to elongate when the device 1200 is in alow-profile configuration within the capsule 1700 (FIG. 13A) duringdelivery or partial deployment. When the device 1200 is fully releasedfrom the capsule 1700 (FIG. 13A) the extension connectors 1210foreshorten to avoid interfering with blood flow along the leftventricular outflow tract.

The extended connectors 1210 further include an attachment element 1214configured to releasably engage a delivery device. The attachmentelement 1214 can be a T-bar or other element that prevents the device1200 from being released from the capsule 1700 (FIG. 13A) of a deliverydevice until desired. For example, a T-bar type attachment element 1214can prevent the device 1200 from moving axially during deployment orpartial deployment until the housing 1702 (FIG. 13A) moves beyond theportion of the delivery device engaged with the attachment elements1214. This causes the attachment elements 1214 to disengage from thecapsule 1700 (FIG. 13A) as the outflow region of the valve support 1110and the base 1122 of the anchoring member 1120 fully expand to allow forfull deployment of the device 1200.

FIG. 19 is a side view and FIG. 20 is a bottom isometric view of thedevice 1200 in a partially deployed state in which the device 1200 isstill capable of being recaptured in the housing 1702 of the deliverydevice 1700. Referring to FIG. 19, the device 1200 is partially deployedwith the fixation structure 1130 substantially expanded but theattachment elements 1214 (FIG. 17) still retained within the capsule1700. This is useful for determining the accuracy of the position of thedevice 1200 and allowing blood to flow through the functioningreplacement valve during implantation while retaining the ability torecapture the device 1200 in case it needs to be repositioned or removedfrom the patient. In this state of partial deployment, the elongatedfirst and second struts 1212 a-b of the extended connectors 1210 spacethe base 1122 of the anchoring member 1120 and the outflow region of thevalve support 1110 (FIG. 12A) apart from the edge 1708 of the capsule1700 by a gap G.

Referring to FIG. 20, the gap G enables blood to flow through theprosthetic valve assembly 1150 while the device 1200 is only partiallydeployed. As a result, the device 1200 can be partially deployed todetermine (a) whether the device 1200 is positioned correctly withrespect to the native heart valve anatomy and (b) whether proper bloodflow passes through the prosthetic valve assembly 1150 while the device1200 is still retained by the delivery system 1700. As such, the device1200 can be recaptured if it is not in the desired location and/or ifthe prosthetic valve is not functioning properly. This additionalfunctionality is expected to significantly enhance the ability toproperly position the device 1200 and assess, in vivo, whether thedevice 1200 will operate as intended, while retaining the ability toreposition the device 1200 for redeployment or remove the device 1200from the patient.

FIG. 21 is an isometric view of a valve support 1300 in accordance withan embodiment of the present technology. The valve support 1300 can bean embodiment of the valve support 1110 described above with respect toFIGS. 12A-20. The valve support 1300 has an outflow region 1302, aninflow region 1304, a first row 1310 of first hexagonal cells 1312 atthe outflow region 1302, and a second row 1320 of second hexagonal cells1322 at the inflow region 1304. For purposes of illustration, the valvesupport shown in FIG. 21 is inverted compared to the valve support 1110shown in FIGS. 12A-20 such that the blood flows through the valvesupport 1300 in the direction of arrow BF. In mitral valve applications,the valve support 1300 would be positioned within the anchoring member1120 (FIG. 12A) such that the inflow region 1304 would correspond toorientation of the inflow region 1112 in FIG. 12A and the outflow region1302 would correspond to the orientation of the outflow region 1114 inFIG. 12A.

Each of the first hexagonal cells 1312 includes a pair of firstlongitudinal supports 1314, a downstream apex 1315, and an upstream apex1316. Each of the second hexagonal cells 1322 can include a pair ofsecond longitudinal supports 1324, a downstream apex 1325, and anupstream apex 1326. The first and second rows 1310 and 1312 of the firstand second hexagonal cells 1312 and 1322 are directly adjacent to eachother. In the illustrated embodiment, the first longitudinal supports1314 extend directly from the downstream apexes 1325 of the secondhexagonal cells 1322, and the second longitudinal supports 1324 extenddirectly from the upstream apexes 1316 of the first hexagonal cells1312. As a result, the first hexagonal cells 1312 are offset from thesecond hexagonal cells 1322 around the circumference of the valvesupport 1300 by half of the cell width.

In the embodiment illustrated in FIG. 21, the valve support 1300includes a plurality of first struts 1331 at the outflow region 1302, aplurality of second struts 1332 at the inflow region 1304, and aplurality of third struts 1333 between the first and second struts 1331and 1332. Each of the first struts 1331 extends from a downstream end ofthe first longitudinal supports 1314, and pairs of the first struts 1331are connected together to form first downstream V-struts defining thedownstream apexes 1315 of the first hexagonal cells 1312. In a relatedsense, each of the second struts 1332 extends from an upstream end ofthe second longitudinal supports 1324, and pairs of the second struts1332 are connected together to form second upstream V-struts definingthe upstream apexes 1326 of the second hexagonal cells 1322. Each of thethird struts 1333 has a downstream end connected to an upstream end ofthe first longitudinal supports 1314, and each of the third struts 1333has an upstream end connected to a downstream end of one of the secondlongitudinal supports 1324. The downstream ends of the third struts 1333accordingly define a second downstream V-strut arrangement that formsthe downstream apexes 1325 of the second hexagonal cells 1322, and theupstream ends of the third struts 1333 define a first upstream V-strutarrangement that forms the upstream apexes 1316 of the first hexagonalcells 1312. The third struts 1333, therefore, define both the firstupstream V-struts of the first hexagonal cells 1312 and the seconddownstream V-struts of the second hexagonal cells 1322.

The first longitudinal supports 1314 can include a plurality of holes1336 through which sutures can pass to attach a prosthetic valveassembly and/or a sealing member. In the embodiment illustrated in FIG.21, only the first longitudinal supports 1314 have holes 1336. However,in other embodiments the second longitudinal supports 1324 can alsoinclude holes either in addition to or in lieu of the holes 1336 in thefirst longitudinal supports 1314.

FIG. 22 is a side view and FIG. 23 is a bottom isometric view of thevalve support 1300 with a first sealing member 1162 attached to thevalve support 1300 and a prosthetic valve 1150 within the valve support1300. The first sealing member 1162 can be attached to the valve support1300 by a plurality of sutures 1360 coupled to the first longitudinalsupports 1314 and the second longitudinal supports 1324. At least someof the sutures 1360 coupled to the first longitudinal supports 1314 passthrough the holes 1336 to further secure the first sealing member 1162to the valve support 1300.

Referring to FIG. 23, the prosthetic valve 1150 can be attached to thefirst sealing member 1162 and/or the first longitudinal supports 1314 ofthe valve support 1300. For example, the commissure portions of theprosthetic valve 1150 can be aligned with the first longitudinalsupports 1314, and the sutures 1360 can pass through both the commissureportions of the prosthetic valve 1150 and the first sealing member 1162where the commissure portions of the prosthetic valve 1150 are alignedwith a first longitudinal support 1314. The inflow portion of theprosthetic valve 1150 can be sewn to the first sealing member 1162.

The valve support 1300 illustrated in FIGS. 21-23 is expected to be wellsuited for use with the device 1200 described above with reference toFIGS. 17-20. More specifically, the first struts 1331 cooperate with theextended connectors 1210 (FIGS. 17-20) of the device 1200 to separatethe outflow portion of the prosthetic valve 1150 from the capsule 1700(FIGS. 19-20) when the device 1200 is in a partially deployed state. Thefirst struts 1331, for example, elongate when the valve support 1300 isnot fully expanded (e.g., at least partially contained within thecapsule 1700) and foreshorten when the valve support is fully expanded.This allows the outflow portion of the prosthetic valve 1150 to bespaced further apart from the capsule 1700 in a partially deployed stateso that the prosthetic valve 1150 can at least partially function whenthe device 1200 (FIGS. 17-20) is in the partially deployed state.Therefore, the valve support 1300 is expected to enhance the ability toassess whether the prosthetic valve 1150 is fully operational in apartially deployed state.

FIGS. 24 and 25 are schematic side views of valve supports 1400 and1500, respectively, in accordance with other embodiments of the presenttechnology. Referring to FIG. 24, the valve support 1400 includes afirst row 1410 of first of hexagonal cells 1412 and a second row 1420 ofsecond hexagonal cells 1422. The valve 1400 can further include a firstrow 1430 of diamond-shaped cells extending from the first hexagonalcells 1412 and a second row 1440 of diamond-shaped cells extending fromthe second hexagonal cells 1422. The additional diamond-shaped cellselongate in the low-profile state, and thus they can further space theprosthetic valve 1150 (shown schematically) apart from a capsule of adelivery device. Referring to FIG. 25, the valve support 1500 includes afirst row 1510 of first hexagonal cells 1512 at an outflow region 1502and a second row 1520 of second hexagonal cells 1522 at an inflow region1504. The valve support 1500 is shaped such that an intermediate region1506 (between the inflow and outflow regions 1502 and 1504) has asmaller cross-sectional area than that of the outflow region 1502 and/orthe inflow region 1504. As such, the first row 1510 of first hexagonalcells 1512 flares outwardly in the downstream direction and the secondrow 1520 of second hexagonal cells 1522 flares outwardly in the upstreamdirection.

EXAMPLES

Several aspects of the present technology are set forth in the followingexamples.

1. A system for delivering a prosthetic heart valve device into a heartof a patient, the system comprising:

-   -   an elongated catheter body; and    -   a delivery capsule carried by the elongated catheter body and        configured to be hydraulically driven between a containment        configuration for holding the prosthetic heart valve device and        a deployment configuration for at least partially deploying the        prosthetic heart valve device,    -   wherein the delivery capsule includes a housing and a platform,        and wherein        -   the housing and the platform define, at least in part, a            first chamber and a second chamber,        -   at least a portion of the delivery capsule is urged towards            the deployment configuration when fluid is at least            partially drained from the first chamber while fluid is            delivered into the second chamber, and        -   at least a portion of the delivery capsule is urged towards            the containment configuration to resheathe at least a            portion of the prosthetic heart valve device when fluid is            at least partially drained from the second chamber and            delivered into the first chamber.

2. The system of example 1, further comprising a manifold at a proximalend region of the elongated catheter body and configured to receive thefluid for delivery to the first and/or second chambers, wherein themanifold comprises a first fluid lumen and first valve in fluidcommunication with the first chamber, and a second fluid lumen and asecond valve in fluid communication with the second chamber.

3. The system of example 2 wherein the first and second valves arethree-way valves.

4. The system of example 2 wherein the manifold is configured to beexternal to the patient during a implantation procedure.

5. The system of example 2 wherein the first fluid lumen is fluidlyisolated from the second fluid lumen.

6. The system of any one of examples 1-5 wherein the delivery capsule isconfigured to axially restrain the prosthetic heart valve device while afirst portion of the prosthetic heart valve device is deployed from thedelivery capsule and to release an axially restrained portion of theprosthetic heart valve device while the first portion of the prostheticheart valve device contacts tissue of a native valve of the heart of thepatient.

7. The system of any one of examples 1-6 wherein the delivery capsule isconfigured to substantially prevent translation of the prosthetic heartvalve device relative to the elongated catheter body while theprosthetic heart valve device moves between the containmentconfiguration and the deployment configuration.

8. The system of any one of examples 1-7, further comprising a biasingdevice positioned along the catheter body and configured to urge thedelivery capsule towards the containment configuration.

9. The system of example 8 wherein the biasing device comprises a springpositioned to be compressed as the delivery capsule moves towards thedeployment configuration to deploy the prosthetic heart valve devicewhen fluid is transferred to the first chamber.

10. The system of any one of examples 1-9, further comprising anengagement shaft extending through at least a portion of the elongatedcatheter body, wherein a distal end region of the engagement shaft isreleasably coupled to the prosthetic heart valve device via one or moreattachment elements, and wherein the one or attachment elements comprisepockets configured to mate with corresponding attachment features of theprosthetic heart valve device.

11. The system of example 10 wherein the attachment features compriseeyelet shaped projections configured to releasably engage correspondingpockets at the distal end region of the engagement shaft.

12. The system of example 10 wherein the attachment features compriseT-shaped projections configured to releasably mate with correspondingT-shaped pockets at the distal end region of the engagement shaft.

13. A system for delivering a prosthetic heart valve device forimplantation at a native heart valve of a patient, the systemcomprising:

-   -   an elongated catheter body;    -   a delivery capsule coupled to the elongated catheter body and        configured to contain the prosthetic heart valve device, wherein        -   the delivery capsule is configured to be hydraulically            driven between a containment configuration for holding the            prosthetic heart valve device and a deployment configuration            for deploying at least a portion of the prosthetic heart            valve device,        -   the delivery capsule includes a housing and a platform that            define, at least in part, a deployment chamber; and    -   an expandable member coupled to the elongated catheter body and        distal to the delivery capsule, wherein the expandable member is        configured to urge the delivery capsule towards the containment        configuration and resheathe at least a portion of the prosthetic        heart valve device when fluid is at least partially drained from        the deployment chamber while fluid is delivered to the        expandable member.

14. The system of example 13 wherein the delivery capsule is configuredto substantially prevent translation of the prosthetic heart valvedevice relative to the elongated catheter body while the prostheticheart valve device is at least partially resheathed.

15. The system of example 13 or 14 wherein the delivery capsule furthercomprises a containment chamber configured to contain the prostheticheart valve device, and wherein the containment chamber is fluidicallysealed from the deployment chamber via the platform.

16. The system of any one of examples 13-15 wherein the expandablemember is a balloon.

17. A method for delivering a prosthetic heart valve device to a nativemitral valve of a heart of a human patient, the method comprising:

-   -   positioning a delivery capsule of an elongated catheter body        within the heart, the delivery capsule carrying the prosthetic        heart valve device;    -   delivering fluid to a first chamber within the delivery capsule        to move the prosthetic heart valve device from a containment        configuration within the delivery capsule to a deployment        configuration, wherein the first chamber is proximal to the        prosthetic heart valve device;    -   while fluid is delivered to the first chamber, draining fluid        from a second chamber within the delivery capsule, wherein the        second chamber is proximal to the prosthetic heart valve device;        and    -   allowing the prosthetic heart valve device to radially expand to        engage tissue of the native mitral valve when the delivery        capsule moves from the containment configuration towards the        deployment configuration.

18. The method of example 17, further comprising:

-   -   urging the delivery capsule toward the containment configuration        to resheathe the prosthetic heart valve device after allowing        the prosthetic heart valve device to at least partially radially        expand, wherein urging the delivery capsule toward the        containment configuration comprises        -   draining fluid from the first chamber; and        -   while draining fluid from the first chamber, delivering            fluid to the second chamber.

19. The method of example 17 or 18 wherein:

-   -   delivering fluid to the first chamber comprises delivering fluid        from a manifold at a proximal portion of the elongated catheter        body via a first fluid lumen; and    -   draining fluid from the second chamber comprises removing fluid        via a second fluid lumen to the manifold.

20. The method of any one of examples 17-19 wherein delivering fluid tothe first chamber and draining fluid from the second chamber at leastsubstantially prevents translation of the prosethetic heart valve devicerelative to the elongated catheter body while the prosthetic heart valvedevice moves from the containment configuration to the deploymentconfiguration.

21. The method of any one of examples 17-20, further comprisingrestraining a distal portion of the prosthetic heart valve device as theprosthetic heart valve device moves between the containment anddeployment configurations, wherein the distal portion of the prostheticheart valve device comprises attachment elements that releasably coupleto pockets at a distal end region of an engagement shaft that extendsthrough the elongated catheter body.

22. The method of example 21, further comprising moving the engagementshaft distally relative to the delivery capsule to release therestrained distal portion of the distal end region of the engagementshaft and fully expand the prosthetic heart valve device.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

I claim:
 1. A system for delivering a prosthetic heart valve device intoa heart of a patient, the system comprising: an elongated catheter body;and a delivery capsule carried by the elongated catheter body andconfigured to be hydraulically driven between a containmentconfiguration for holding the prosthetic heart valve device and adeployment configuration for at least partially deploying the prostheticheart valve device, wherein the delivery capsule includes a housing anda platform, wherein the housing and the platform define boundaries of afirst chamber and a second chamber; and a manifold at a proximal endregion of the elongated catheter body and configured to receive fluidfor delivery to at least one of the first or second chambers, whereinthe manifold comprises a first fluid lumen and first valve in fluidcommunication with the first chamber, and a second fluid lumen and asecond valve in fluid communication with the second chamber, wherein atleast a portion of the delivery capsule is urged proximally towards thedeployment configuration when fluid is at least partially drained fromthe first chamber while fluid is delivered into the second chamber, andwherein at least a portion of the delivery capsule is urged distallytowards the containment configuration to resheathe at least a portion ofthe prosthetic heart valve device when fluid is at least partiallydrained from the second chamber and delivered into the first chamber. 2.The system of claim 1 wherein the first and second valves are three-wayvalves.
 3. The system of claim 1 wherein the manifold is configured tobe external to the patient during an implantation procedure.
 4. Thesystem of claim 1 wherein the first fluid lumen is fluidly isolated fromthe second fluid lumen.
 5. The system of claim 1 wherein the deliverycapsule is configured to axially restrain the prosthetic heart valvedevice while a first portion of the prosthetic heart valve device isdeployed from the delivery capsule and to release an axially restrainedportion of the prosthetic heart valve device while the first portion ofthe prosthetic heart valve device contacts tissue of a native valve ofthe heart of the patient.
 6. The system of claim 1 wherein the deliverycapsule is configured to substantially prevent translation of theprosthetic heart valve device relative to the elongated catheter bodywhile the delivery capsule transitions between the containmentconfiguration and the deployment configuration.
 7. The system of claim1, further comprising a biasing device positioned along the elongatedcatheter body and configured to urge the delivery capsule towards thecontainment configuration.
 8. The system of claim 7 wherein the biasingdevice comprises a spring positioned to be compressed as the deliverycapsule moves towards the deployment configuration to deploy theprosthetic heart valve device when fluid is transferred to the firstchamber.
 9. The system of claim 1, further comprising an engagementshaft extending through at least a portion of the elongated catheterbody, wherein a distal end region of the engagement shaft is releasablycoupled to the prosthetic heart valve device via one or more attachmentelements, and wherein the one or more attachment elements comprisepockets configured to mate with corresponding attachment features of theprosthetic heart valve device.
 10. The system of claim 9 wherein theattachment features comprise eyelet shaped projections configured toreleasably engage corresponding pockets at the distal end region of theengagement shaft.
 11. The system of claim 9 wherein the attachmentfeatures comprise T-shaped projections configured to releasably matewith corresponding T-shaped pockets at the distal end region of theengagement shaft.